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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215658

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NDA 215658 describes GANIRELIX ACETATE, which is a drug marketed by Amphastar Pharms Inc, Gland, Lupin Ltd, Meitheal, Organon Usa Organon, Qilu, and Tris Pharma Inc, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the GANIRELIX ACETATE profile page.

The generic ingredient in GANIRELIX ACETATE is ganirelix acetate. There are four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ganirelix acetate profile page.

Summary for 215658

Tradename:	GANIRELIX ACETATE
Applicant:	Gland
Ingredient:	ganirelix acetate
Patents:	0

Pharmacology for NDA: 215658

Mechanism of Action	Gonadotropin Releasing Hormone Receptor Antagonists
Physiological Effect	Decreased GnRH Secretion

Suppliers and Packaging for NDA: 215658

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	215658	ANDA	Fresenius Kabi USA, LLC	65219-028	65219-028-05	1 SYRINGE, GLASS in 1 CARTON (65219-028-05) / 1 mL in 1 SYRINGE, GLASS
GANIRELIX ACETATE	ganirelix acetate	INJECTABLE;INJECTION	215658	ANDA	Gland Pharma Limited	68083-472	68083-472-01	1 BLISTER PACK in 1 CARTON (68083-472-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	250MCG/0.5ML
Approval Date:	Feb 28, 2023	TE:	AP	RLD:	No

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